LEADER EYE ITCH RELIEF DROPS - ketotifen fumarate solution/ drops 
HANLIM PHARM. CO., LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient                                             Purpose

Ketotifen (0.025%)..........................................Antihistamine

(Equivalent to ketotifen fumarate 0.035%)

Use

Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Warnings

Do not use


When using this product

Stop use and ask a doctor if you experience any of the following:

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

benzalkonium chloride 0.01%, glycerol, sodium hydroxide and/or hydrochloric acid, and water for injection

image of carton labelEnter section text here

LEADER EYE ITCH RELIEF DROPS 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11716-1163
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN FUMARATE0.345 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11716-1163-71 in 1 CARTON
15 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34904/21/2010
Labeler - HANLIM PHARM. CO., LTD. (687986034)
Registrant - UNITED EXCHANGE CORP. (840130579)

Revised: 4/2010
Document Id: 2fd8e64f-8fa0-43d6-b48d-a1246b7e557a
Set id: 7e6c8a0c-31ea-429b-890b-544142805790
Version: 1
Effective Time: 20100421
 
HANLIM PHARM. CO., LTD.